Pododigital
FDA 510(k) K864569 · Broadwest Corp.
510(k) numberK864569
Submission
- Device name
- Pododigital
- Applicant
- Broadwest Corp.
New York, NY, US - Received
- November 20, 1986
- Decision date
- February 4, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IKE – Transducer, Miniature Pressure
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.1615
- Specialty
- Physical Medicine
Other 510(k)s with product code IKE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K060125 | Sonic PalpometerIKE · Traditional | Palpometer Systems, Inc. | 03/16/2006SE |
| K954670 | Pressore MonitorIKE · Traditional | Cleveland Medical Devices, Inc. | 10/30/1995SE |
| K915369 | The EqualizerIKE · Traditional | Advanced Rehabilitative Technology, Inc. | 03/22/1993SE |
| K915326 | Portable Limb Load Monitor (BMLLM-100)IKE · Traditional | Bar Med Pty , Ltd. | 10/20/1992SE |
| K920091 | Iowa Oral Performance IsntrumentIKE · Traditional | Breakthrough, Inc. | 05/20/1992SE |
| K915897 | FPLIKE · Traditional | Wrm Computers | 04/07/1992SE |
| K914780 | Talley SD.500 Skin Pressure EvaluatorIKE · Traditional | Talley Group, Ltd. | 12/19/1991SE |
| K902967 | Micro-Emed-SystemIKE · Traditional | Novel Electronics, Inc. | 09/17/1990SE |
| K880912 | Dynatron 2000IKE · Traditional | Dynatronics Corp. | 03/15/1988SE |
| K875103 | Bio-Feedback Limb Monitor Type Code BL-34-1IKE · Traditional | Shield Computers , Ltd. | 01/20/1988SE |
More from Shield Computers , Ltd.
Questions and answers
When was Pododigital cleared by the FDA?
Pododigital (K864569) received a 510(k) decision of Substantially Equivalent on February 4, 1987, 76 days after the submission was received.
What is the product code of K864569?
The FDA product code is IKE – Transducer, Miniature Pressure, a Class I (low risk) device regulated under 21 CFR 890.1615.